CLERMONT-FERRAND, France & DIJON, France--(EON: Enhanced Online News)--ONCODESIGN (Paris:ALONC) (ALONC – FR0011766229), a biopharmaceutical
company specializing in precision medicine, and CYCLOPHARMA, a company
developing leading molecular imaging solutions, in cooperation with
Centre Georges François Leclerc (CGFL), the regional cancer research and
treatment center for Burgundy, have announced promising results for the
Phase 1 study of the first radiotracer 1 to come out of the
IMAkinib program.

The radiotracer, labelled with radioactive 18F-fluorine, is a
molecule generated using Oncodesign’s Nanocyclix technology whose use as
a companion biomarker in targeted EGFR inhibitor therapy2 is
being assessed in patients with lung tumors.

The current clinical study has as its primary objective the assessment
of the clinical advantages of the radiotracer using PET3, by
determining its sensitivity and specificity in patients with pulmonary
tumors treated with targeted anti-EGFR therapy. It is the product of
cooperation between Centre Georges François Leclerc, Cyclopharma and
Oncodesign as part of the Dijon-based Pharmimage cluster.

The first stage of the clinical trial, in 8 patients with EGFR
mutations, has produced very encouraging results in terms of product
safety, dosage and fixing on pulmonary tumors expressing mutated EGFR.
These results allow the launch of the second stage of the clinical
study, with the inclusion of 6 new patients with non-mutated EGFR
receptors. The aim of this second stage is to demonstrate the
radiotracer’s specificity.

Full results from the Phase 1 study are expected in the first half of
2018. Positive results would directly allow the design of a Phase 3
clinical study, with the final objective of application for Marketing
Authorization.

“Measuring EGFR receptor activity in lung cancer enables early
detection of tumor resistance to anti-EGFR therapies, and thus better
care for patients,” said Philippe Genne, founder, Chairman and CEO
of Oncodesign. “In comparison with other types of companion
biomarkers, using liquid or solid biopsy techniques, the advantage of a
PET-based approach is that it gives clinicians an idea of the
heterogeneity of the disease in the whole of the patient’s body.
Together with our partners we have been pioneers in this approach.”

Activating mutations for EGFR kinase are a cause of non-small cell
pulmonary adenocarcinomas, which represent between 10% and 15% of lung
cancers in the Caucasian population and between 30% and 50% of those in
patients of Asian origin. This type of cancer affects nearly 6,000
patients in France each year, with a projection of 1.3 million patients
worldwide by 2022 (up 22% in 10 years). The main treatments for this
pathology include tyrosine kinase inhibitors that target EGFR, meaning
that the use of a biomarker that can help clinicians in their selection
of treatments is a major step forward in precision medicine.

Founded over 20 years ago by Dr Philippe Genne, the Company’s CEO and
Chairman, Oncodesign is a biopharma company dedicated to the precision
medicine. With its unique experience acquired by working with more than
600 clients, including the world’s largest pharmaceutical companies,
along with its comprehensive technological platform combining
state-of-the-art medicinal chemistry, pharmacology, regulated
bioanalysis and medical imaging, Oncodesign is able to predict and
identify, at a very early stage, each molecule's therapeutic usefulness
and potential to become an effective drug. Applied to kinase inhibitors,
which represent a market estimated at over $46 billion in 2016 and
accounting for almost 25% of the pharmaceutical industry’s R&D
expenditure, Oncodesign’s technology has already enabled the targeting
of several promising molecules with substantial therapeutic potential,
in oncology and elsewhere, along with partnerships with pharmaceutical
groups such as Bristol-Myers Squibb and UCB. Oncodesign is based in
Dijon, France, in the heart of the town’s university and hospital hub,
and within the Paris-Saclay cluster, Oncodesign has 220 employees and
subsidiaries in Canada and the USA.

Since its creation in 2000, Cyclopharma has developed molecular imaging
solutions to allow the observation of cell function in vivo as
part of the targeted treatment of cancer, in order to improve
individualized treatment plans for patients in terms of diagnostics,
monitoring and therapeutic effectiveness, whilst also reducing costs.

With more than 120 employees and revenue of €23 million, Cyclopharma
invests more than 10% of revenue in research into novel molecular
imaging tracers. Since 2015 it has built on dense and balanced
geographical coverage to drive international growth, with the aim of
becoming a major European force in personalized medicine.

The cancer center Georges-François Leclerc, founded in 1967, is the only
healthcare facility exclusively dedicated to oncology for the whole
region of Burgundy / Franche-Comté. In 50 years, it has become a
reference center located between Paris and Lyon for the fight against
cancer and for the benefit of 22,000 patients treated each year with the
development of multiple innovative activities: molecular medicine,
genomics, immunotherapy, pre-clinical and clinical imaging, early
development of new drugs, high-precision radiotherapy, ambulatory
surgery, quality of life.

Its internationally renowned team of physicians-researchers offers a
personalized medicine and a research that directly benefits patients
through its state-of-the-art platforms listed in the catalog of the
University of Burgundy among which one for early clinical research, the
only one in the whole Great East of France to be labeled by the National
Cancer Institute. Centre Georges-François Leclerc has conducted research
on an advanced personalization of treatments by having a comprehensive
view, from basic research to clinical research. The CGFL is the only
institution in our region that prohibits its physicians from having a
liberal activity and overrun fees, thus offering all patients an access
to innovative care without anything to pay. With 10% of its annual
budget (€ 85M) devoted to research, 771 employees including 133 medical
doctors and 48 researchers, this private nonprofit health institution,
with public service missions of care, training and cancer research, is
responsible for more than 22,000 patients each year, including 4,800
inpatients. Centre Georges-François Leclerc is a member of the Unicancer
Group.

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